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Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY) (GALAXY)

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ClinicalTrials.gov Identifier: NCT00836589
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Patients Indicated for an ICD
Intervention Device: ICD Therapy - ICD Lead Registry
Enrollment 1997
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Data Collection Group
Hide Arm/Group Description ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
Period Title: Overall Study
Started 1997
Completed 731
Not Completed 1266
Reason Not Completed
Lost to Follow-up             246
Death             429
Withdrawal by Subject or Physician             591
Arm/Group Title Data Collection Group
Hide Arm/Group Description ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
Overall Number of Baseline Participants 1997
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age at Enrollment Number Analyzed 1997 participants
64.5  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1997 participants
Female
537
  26.9%
Male
1460
  73.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 1997 participants
White
1298
  65.0%
Black or African American
288
  14.4%
Hispanic or Latino
244
  12.2%
Unknown
139
   7.0%
Asian
21
   1.1%
Native Hawaiian or Other Pacific Islander
4
   0.2%
Amerian Indian or Alaska Native
3
   0.2%
Height  
Mean (Standard Deviation)
Unit of measure:  In
Number Analyzed 1997 participants
68.0  (4.0)
Weight  
Mean (Standard Deviation)
Unit of measure:  Lbs
Number Analyzed 1997 participants
194.2  (49.4)
1.Primary Outcome
Title Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead
Hide Description The overall incidence of complications (serious adverse events that require additional invasive intervention to resolve or specific non-invasive actions) related to the Linox ICD leads implanted with a market-released BIOTRONIK ICD device was evaluated. This was evaluated as a serious adverse event free-rate (SAEFR).
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event.
Arm/Group Title Data Collection Group
Hide Arm/Group Description:
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
Overall Number of Participants Analyzed 777
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
90.9
(88.6 to 92.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Data Collection Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments

Estimated SAEFR at 5 years is 92.5% with a 5% non-inferiority margin (87.5%).

Type I error (alpha) is 0.05 (one-sided for non-inferiority).

Statistical power is 80%.

Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method Binomial Proportion
Comments [Not Specified]
2.Primary Outcome
Title Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
Hide Description Evaluation of the individual types of serious adverse events (SAEs) contributing to primary outcome 1 and their associated SAE category.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event.
Arm/Group Title Data Collection Group
Hide Arm/Group Description:
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
Overall Number of Participants Analyzed 777
Measure Type: Count of Participants
Unit of Measure: Participants
Low lead impedance, potential insulation breach 25
High lead impedance, potential conductor fracture 20
Lead noise or oversensing 17
Lead dislodgement (>180 days post-implant) 6
Lead undersensing or loss of sensing 2
Inability to defibrillate or pace 1
No slack in lead due to probable dislodgement 1
Noise consistent with probable fracture 1
Tension pneumothorax 1
3.Secondary Outcome
Title Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (ICD, Device, and Implant Procedure Related) Through 5 Years Post-Implant.
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a secondary endpoint adverse event (ICD lead, device, implant procedure, or other related).
Arm/Group Title Data Collection Group
Hide Arm/Group Description:
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
Overall Number of Participants Analyzed 830
Measure Type: Count of Participants
Unit of Measure: Participants
Total related to the ICD lead 42
Total device related 6
Total implant procedure related 58
Total other AEs 22
4.Secondary Outcome
Title Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant.
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and had an RA lead implanted for any duration and/or who experienced a secondary endpoint adverse event (RA lead related).
Arm/Group Title Data Collection Group
Hide Arm/Group Description:
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
Overall Number of Participants Analyzed 562
Measure Type: Number
Unit of Measure: subjects with adverse event
39
5.Secondary Outcome
Title Pacing Threshold Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
Hide Description Pacing thresholds performed at 0.5 ms pulse-width were requested. Threshold data reported below was collected at 0.5 ms pulse-width. The mean pacing threshold is calculated as a mean across all study visits.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
17 subjects were excluded due to incomplete data.
Arm/Group Title Linox Lead System
Hide Arm/Group Description:
Linox leads including S, SD, T, and TD models, Linox smart leads including smart S, smart SD, and smart TD models.
Overall Number of Participants Analyzed 1980
Mean (Standard Deviation)
Unit of Measure: Volts (V)
0.64  (0.35)
6.Secondary Outcome
Title Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
Hide Description The mean sensing measurement is calculated as a mean across all study visits.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
17 subjects were excluded due to incomplete data.
Arm/Group Title Linox Lead System
Hide Arm/Group Description:
Linox leads including S, SD, T, and TD models, Linox smart leads including smart S, smart SD, and smart TD models.
Overall Number of Participants Analyzed 1980
Mean (Standard Deviation)
Unit of Measure: millivolts (mV)
12.77  (5.40)
7.Secondary Outcome
Title Pacing Impedance Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
Hide Description The mean pacing impedance measurement is calculated as a mean across all study visits.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
17 subjects were excluded due to incomplete data.
Arm/Group Title Linox Lead System
Hide Arm/Group Description:
Linox leads including S, SD, T, and TD models, Linox smart leads including smart S, smart SD, and smart TD models.
Overall Number of Participants Analyzed 1980
Mean (Standard Deviation)
Unit of Measure: ohms
552.9  (136.4)
8.Secondary Outcome
Title Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model.
Hide Description Pacing thresholds performed at 0.5 ms pulse-width were requested. Threshold data reported below was collected at 0.5 ms pulse-width. The mean pacing threshold of each Linox Lead System model was calculated as a mean across all study visits.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Linox S Linox SD Linox T Linox TD Linox Smart S Linox Smart SD Linox Smart TD
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 338 1352 1 88 24 173 4
Mean (Standard Deviation)
Unit of Measure: Volts (V)
0.62  (0.31) 0.64  (0.33) 0.50  (0.00) 0.76  (0.62) 0.59  (0.22) 0.66  (0.46) 0.67  (0.31)
9.Secondary Outcome
Title Individual Electrical Parameters (Sensing) of Each Linox Lead System Model.
Hide Description The mean sensing measurements of each Linox Lead System model were calculated as a mean across all study visits.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Linox S Linox SD Linox T Linox TD Linox Smart S Linox Smart SD Linox Smart TD
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 338 1352 1 88 24 173 4
Mean (Standard Deviation)
Unit of Measure: millivolts (mV)
13.66  (5.69) 12.71  (5.41) 5.63  (0.81) 10.96  (4.06) 13.12  (5.14) 12.25  (4.93) 10.25  (1.46)
10.Secondary Outcome
Title Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model.
Hide Description The mean pacing impedance of each Linox Lead System model was calculated as a mean across all study visits.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Linox S Linox SD Linox T Linox TD Linox Smart S Linox Smart SD Linox Smart TD
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 338 1352 1 88 24 173 4
Mean (Standard Deviation)
Unit of Measure: ohms
550.9  (105.3) 541.8  (120.5) 812.0  (202.5) 784.8  (306.2) 541.5  (106.5) 546.0  (99.2) 734.4  (253.8)
Time Frame Implant to Study Exit (up to 5 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Data Collection Group
Hide Arm/Group Description ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
All-Cause Mortality
Data Collection Group
Affected / at Risk (%)
Total   429/1997 (21.48%)    
Hide Serious Adverse Events
Data Collection Group
Affected / at Risk (%) # Events
Total   215/1997 (10.77%)    
Cardiac disorders   
ICD lead dislodgement (occuring <= 180 days post-implant procedure)  24/1997 (1.20%)  25
ICD lead high pacing threshold, intermittent capture, no lead capture  12/1997 (0.60%)  13
ICD lead related cardiac perforation with or without tamponade  5/1997 (0.25%)  6
ICD lead impedance out of range, low impedance, potential insulation break  25/1997 (1.25%)  25
ICD lead impedance out of range, high impedance, potential conductor fracture  18/1997 (0.90%)  18
Other ICD lead related: lead noise or oversensing  17/1997 (0.85%)  17
ICD lead dislodgement (occuring > 180 days post-implant procedure)  6/1997 (0.30%)  6
ICD lead undersensing or loss of sensing  2/1997 (0.10%)  2
ICD lead inability to defibrillate or pace  1/1997 (0.05%)  1
Other ICD lead related: no slack in the lead due to probable dislodgement  1/1997 (0.05%)  1
Other ICD lead related: noise consistent with probable fracture  1/1997 (0.05%)  1
Other ICD lead related: tension pneumothorax  1/1997 (0.05%)  1
Pocket pain  2/1997 (0.10%)  2
Unable to interrogate device  2/1997 (0.10%)  2
Suspected generator failure  1/1997 (0.05%)  1
Premature battery depletion, warranting device replacement  1/1997 (0.05%)  1
RA lead dislodgement  18/1997 (0.90%)  18
RA lead impedance out of range, high impedance, potential conductor fracture  2/1997 (0.10%)  3
RA lead undersensing or loss of sensing  3/1997 (0.15%)  3
RA lead oversensing or noise  1/1997 (0.05%)  1
RA lead high pacing threshold, intermittent capture, no lead capture  1/1997 (0.05%)  1
RA lead loose set screw  1/1997 (0.05%)  1
Pulseless electrical activity (PEA) arrest  1/1997 (0.05%)  1
LV lead dislodgement  1/1997 (0.05%)  1
Thrombus attached to ICD lead (unrelated to ICD lead)  1/1997 (0.05%)  1
General disorders   
Twiddler's syndrome  5/1997 (0.25%)  6
Infections and infestations   
Infection not due to secondary infection  27/1997 (1.35%)  27
Infection due to secondary infection  14/1997 (0.70%)  14
Skin and subcutaneous tissue disorders   
Skin erosion  1/1997 (0.05%)  1
Surgical and medical procedures   
Hematoma  7/1997 (0.35%)  7
Loose set screw  4/1997 (0.20%)  4
Non-healing pocket dehiscence requiring intervention  3/1997 (0.15%)  3
Bleeding  1/1997 (0.05%)  1
Deep vein thrombosis  1/1997 (0.05%)  1
Impending erosion  1/1997 (0.05%)  1
Pain at insertion site  1/1997 (0.05%)  1
Pocket erosion  1/1997 (0.05%)  1
Pulmonary embolism (unrelated to ICD lead)  1/1997 (0.05%)  1
Shock coils reversed in header  1/1997 (0.05%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Data Collection Group
Affected / at Risk (%) # Events
Total   31/1997 (1.55%)    
Cardiac disorders   
ICD lead high pacing threshold, intermittent capture, no lead capture  2/1997 (0.10%)  2
ICD lead impedance out of range, high impedance, potential conductor fracture  2/1997 (0.10%)  2
RA lead dislodgement  11/1997 (0.55%)  11
RA lead impedance out of range, high impedance, potential conductor fracture  1/1997 (0.05%)  1
RA lead oversensing or noise  2/1997 (0.10%)  2
Infections and infestations   
Infection not due to secondary infection  1/1997 (0.05%)  1
Surgical and medical procedures   
Hematoma  12/1997 (0.60%)  13
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Principal Investigators agree to submit copies of any manuscript proposed for publication to Sponsor for review at least 30 days in advance of submission for publication or presentation. Sponsor may extend such review period for another 90 days to file patent applications or take other steps to protect its intellectual property interests, or to remove from the paper or presentation any language that is detrimental to Sponsor's intellectual property interests
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kelly Mohr
Organization: BIOTRONIK, INC
Phone: 800-547-0394
EMail: kelly.mohr@biotronik.com
Layout table for additonal information
Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00836589    
Other Study ID Numbers: GALAXY
First Submitted: February 2, 2009
First Posted: February 4, 2009
Results First Submitted: December 18, 2017
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019